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Santhera Announces Full Enrollment of ReveraGen’s Pivotal VISION-DMD Study With Vamorolone in Duchenne Muscular Dystrophy


Santhera Pharmaceuticals announces that partner ReveraGen Biopharma Inc. has completed enrollment into the pivotal VISION-DMD study with vamorolone in patients with Duchenne muscular dystrophy (DMD). Subject to a positive study outcome, this could allow for a regulatory submission to the US FDA in the fourth quarter of 2021 with the potential to offer an alternative to current standard of care in young boys with DMD.

The 48-week Phase 2b VISION-DMD study (VBP15-004; clinicaltrials.gov: NCT03439670) is designed as a pivotal trial to demonstrate efficacy and safety of vamorolone administered orally at doses of 2.0 mg/kg/day and 6.0 mg/kg/day versus prednisone 0.75 mg/kg/day and placebo in ambulant boys ages 4 to <7 years with DMD. Efficacy outcome measures after the first 24-week treatment period are muscle strength and motor function outcomes with Time to Stand test (TTSTAND) as the primary study endpoint.

 

Santhera Announces Full Enrollment Of ReveraGen’s Pivotal VISION-DMD Study With Vamorolone In Duchenne Muscular Dystrophy